Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000074392
Ethics application status
Approved
Date submitted
7/02/2008
Date registered
8/02/2008
Date last updated
30/08/2019
Date data sharing statement initially provided
30/08/2019
Date results information initially provided
30/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Despatch Trial: DElivering Stroke Prevention for patients with ATrial fibrillation: a Cluster randomised controlled trial in a primary Health care setting.
Scientific title
Does a multifaceted educational intervention targetting general practitioners increase anticoagulant prescribing in patients over the age of 65 with atrial fibrillation compared with evidence-based guidelines? A cluster randomised controlled trial
Secondary ID [1] 273415 0
Nil
Universal Trial Number (UTN)
Trial acronym
Despatch
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 2799 0
Condition category
Condition code
Cardiovascular 2935 2935 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Despatch is a multifaceted, tailored educational intervention to redress noted barriers to the translation of best evidence into clinical practice relevant to the management of atrial fibrillation. Despatch will consist of the following components:
a) decisional support through a specifically created “Stop Stroke” specialist tele-service. b) Academic detailing: The “Stop-Stroke” members will include nurses with training in stroke medicine who will be employed as academic detailers. Academic detailing sessions will be delivered via three telephone sessions.
c) GP, patient and practice decision tools

The intervention will be delivered over a 12-month period after GP randomisation.

Outcomes will be assessed using data collected from patient medical records.
Intervention code [1] 2540 0
Behaviour
Comparator / control treatment
GPs randomised to a the Control will receive evidence-based guidelines by mail

Outcomes will be assessed using data collected from patient medical records.
Control group
Active

Outcomes
Primary outcome [1] 3818 0
Proportion of patients over the age of 65 with a diagnosis of atrial fibrillation who have been prescribed warfarin.
Timepoint [1] 3818 0
1) Note of a prescription at any time during the 12-months after GP randomisation.
2) Note of a prescription current at 12-months post-randomisation
Secondary outcome [1] 6434 0
Proportion of patients prescribed antithrombotic treatment judged as "appropriate" according to stroke risk using a validated evidence-based risk stratification scheme and evidence-based guidelines
Timepoint [1] 6434 0
1) Note of an "appropriate" prescription at any time from time of GP randomisation up to 12-months after GP randomisation.
2) Appropriate antithrombotic treatment current at 12-months post-randomisation
Secondary outcome [2] 6435 0
Percentage of time patients are on warfarin.
Timepoint [2] 6435 0
From time of GP randomisation up to 12-months post-randomisation.
Secondary outcome [3] 6436 0
Time on warfarin: (survival analysis) Time from "initiation" of warfarin until ceasation (or end of follow-up period) will be calculated.
Timepoint [3] 6436 0
Measured over 12-months from GP randomisation.
Secondary outcome [4] 6437 0
Proportion of patients over the age of 65 who are receiving appropriate antithrombotic treatment. The appropriateness of warfarin will be judged according to the "quality control" of anticoagulation as assessed using standardised criteria and definitions.
Timepoint [4] 6437 0
12-months
Secondary outcome [5] 6438 0
Proportion of patients with a record of having experienced an ischaemic Stroke
Timepoint [5] 6438 0
12 months
Secondary outcome [6] 6439 0
Proportion of patients with a record of having experienced a Haemorrhagic stroke
Timepoint [6] 6439 0
12 months
Secondary outcome [7] 6440 0
Proportion of patients with a record of having experienced a stroke, (type not otherwise specified)
Timepoint [7] 6440 0
12 months
Secondary outcome [8] 6441 0
Proportion of patients with a record of having experienced "minor" bleeding. Classification of bleeding using standardised definitions applied in previous clinical trials.
Timepoint [8] 6441 0
12 months
Secondary outcome [9] 6442 0
Proportion of patients with a record of having experienced "major bleeding".
Classification of bleeding using standardised definitions applied in previous clinical trials.
Timepoint [9] 6442 0
12 months
Secondary outcome [10] 6443 0
Proportion of patients with a record of having experienced any cerebrovascular event (ischaemic stroke, haemorrhagic stroke, stroke not otherwise specified)
Timepoint [10] 6443 0
12 months

Eligibility
Key inclusion criteria
This is a cluster randomised controlled trial with general practices designated the unit of randomisation. Outcome measures will be assessed using patient data derived from medical records.

Inclusion criteria:
1) GPs with a practice location within Sydney Metropolitan Area.
2) GPs must utilise an electronic data-base for issuing prescriptions and recording patient information (sex, age, contact details).

Inclusion criteria for patients:
1) Aged older than 65 years
2) Ability to provide consent for medical record audit.
Minimum age
N/A
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for GPs:

GPs engaged primarily in "special interest practice" with limited contact of elderly patients (> 65 years of age) will be considerd ineligible to participate.

GPs in part-time practice (2 days a week or less) will initially be considered ineligible. However, this ineligibility criterion will be reviewed depending on the rate of recruitment of GPs and feasibility of recruitment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation was performed by a senior statistician , from the Clinical Epidemiology Program at the Ottawa Hospital Research Institute, Canada. The statistican was not .otherwise involved in the study and therefore had not been involved in study design or participant recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The exact sequence of randomisation will be determined by the biostatistician. At a minimum, permuted block randomisation will be performed using random block sizes. Randomisation will be stratified by practice size (that is, by the number of GPs per cluster)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/12/2008
Actual
22/10/2008
Date of last participant enrolment
Anticipated
Actual
8/10/2009
Date of last data collection
Anticipated
Actual
13/10/2010
Sample size
Target
2000
Accrual to date
Final
1116
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 568 0
2000

Funding & Sponsors
Funding source category [1] 3059 0
Government body
Name [1] 3059 0
NHMRC
Country [1] 3059 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
National Health & Medical Research Council, Level 5, 20 Allara Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 2757 0
None
Name [1] 2757 0
Address [1] 2757 0
Country [1] 2757 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5011 0
The University of New South Wales, Human Research Ethics Committee
Ethics committee address [1] 5011 0
The University of New South Wales
KENSINGTON UNSW NSW 2052
Ethics committee country [1] 5011 0
Australia
Date submitted for ethics approval [1] 5011 0
Approval date [1] 5011 0
09/05/2007
Ethics approval number [1] 5011 0
HREC 07068

Summary
Brief summary
Non-valvular atrial fibrillation (NVAF) is a common heart condition associated with a major risk of fatal and disabling stroke. Inexpensive anticoagulant medication has been proven to reduce all-cases of death and stroke in people with NVAF.

Anticoagulant treatment for NVAF is substantially underused resulting in avoidable patient deaths and disabling stroke. This study seeks to optimise the management of NVAF in general practice.

We are developing an educational program for general practitioners which we hypothesis will increase the number of people with NVAF over the age of 65 who are prescribed anticoagulant medication.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 28356 0
Dr Melina Gattellari
Address 28356 0
Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170
Country 28356 0
Australia
Phone 28356 0
61 2 8738 9281
Fax 28356 0
02 87389281
Email 28356 0
melina.gattellari@health.nsw.gov.au
Contact person for public queries
Name 11513 0
Dr Dr Melina Gattellari
Address 11513 0
Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170
Country 11513 0
Australia
Phone 11513 0
61 2 8738 9281
Fax 11513 0
None
Email 11513 0
Melina.Gattellari@sswahs.nsw.gov.au
Contact person for scientific queries
Name 2441 0
Dr Dr Melina Gattellari
Address 2441 0
Ingham Institute of Applied Medical Research
1 Campbell Street
LIVERPOOL NSW 2170
Country 2441 0
Australia
Phone 2441 0
61 2 8738 9281
Fax 2441 0
Email 2441 0
Melina.Gattellari@sswahs.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4450Study protocolGattellari M, Leung DY, Ukoumunne OC, Zwar N, Grimshaw J, Worthington JM. Study Protocol. The DESPATCH study: Delivering Stroke Prevention for patients with atrial fibrillation. A cluster randomised controlled trial in primary health care. Implementation Science 2011 http://www.implementationscience.com/content/6/1/48  


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo Gattellari M, Oldmeadow C, Pelazzi K, Leung D, Zwa... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol: the DESPATCH study: delivering stroke prevention for patients with atrial fibrillation - a cluster randomised controlled trial in primary healthcare.2011
N.B. These documents automatically identified may not have been verified by the study sponsor.